This year’s flu season is shaping up to be a nasty one—driven by a new variant of the influenza virus that may be able to slip past our vaccine defenses. A mutated form of the influenza A strain H3N2 ...
KORU Medical has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) seeking approval for its FreedomEDGE infusion system. The submission is intended for using the ...
MAHWAH, N.J.--(BUSINESS WIRE)--KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and ...
NEW YORK - The US Food and Drug Administration granted 510(k) marketing clearances in November to Roche Molecular Systems, Cytovale, Truvian Health, and others for infectious disease pathogen ...
Several ASX healthcare names secured US Food and Drug Administration approval in 2025, opening up the world’s largest healthcare market PainChek’s Adult App became first regulated device to assess ...
SAN FRANCISCO - SleepRes, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP), for the treatment of ...
Please provide your email address to receive an email when new articles are posted on . The device is the first to gain FDA clearance to monitor delirium. The device’s algorithm was validated with ...
Dental AI company Pearl was granted FDA 510(k) clearance for the detection of dental pathologies on panoramic X-rays. Pearl’s Second Opinion platform is now available to use to identify caries, ...
SAN FRANCISCO--(BUSINESS WIRE)--SleepRes, Inc., a sleep technology company focused on reimagining therapy for sleep breathing disorders, today announced that it has received U.S. Food and Drug ...
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